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ENROLLING BY INVITATION
NCT07234500
NA

Evaluation of a Mobile Application Designed to Support Type 1 Diabetic Patients in Adjusting Their Insulin Doses.

Sponsor: University of Baghdad

View on ClinicalTrials.gov

Summary

Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients. The goal of this clinical trial is to determine whether a mobile health application can improve insulin management and blood sugar control in Iraqi patients with Type 1 Diabetes aged over 15 years who are on intensive insulin therapy. The main question it aims to answer is: Does the use of the mobile application lead to a greater reduction in HbA1c levels compared to standard care alone? Researchers will compare the group using the mobile application to the group receiving standard care alone to see if the application is more effective at improving glycemic control. Participants will: Be randomly assigned to one of two groups for the 3-month study. Either use the mobile application to guide their daily insulin dose adjustments alongside standard care, or receive standard care alone. Undergo blood tests (including HbA1c) and complete questionnaires about hypoglycemic events, insulin adherence, and quality of life.

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-09-01

Completion Date

2026-07

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DEVICE

mHealth Mobile Application

This is a culturally and linguistically tailored mobile health (mHealth) application designed for Arabic-speaking patients with Type 1 Diabetes in Iraq. The core function is to assist in calculating precise pre-meal insulin bolus doses by integrating: (1) carbohydrate intake, (2) current blood glucose level, and (3) planned physical activity. Key tailored features include: a database of common Arabic cuisine for easy carbohydrate counting using food photographs (aiding patients with low health literacy), full Arabic language support, and algorithms calibrated for insulin types available in the Iraqi market. The app automatically calculates personalized insulin-to-carbohydrate ratios and correction factors based on the patient's total daily insulin dose, removing the need for manual entry and complex calculations.

OTHER

Standard Care (in control arm)

Routine clinical management for type 1 diabetes, including regular insulin dose adjustments based on standard practice (e.g., clinic visits, HbA1c monitoring).

Locations (1)

Faiha Specialized Diabetes, Endocrine and Metabolism Center at Al-Faiha Teaching hospital

Basra, Basrah, Iraq